Glaucoma Filtering Surgery Comparison: SIBS and Gelatin Microshunts versus Trabeculectomy
Authors: Tarek A. Bin Yameen, James Armstrong, Lotte Scheres, Paola Marolo, Sophie Lemmens, Eunice Chew, BrahimKhouri, Henny Beckers, AntonioFea, Ingeborg Stalmans, ChelvinSng, William McCollum, Juan Battle, Matthew Schlenker, Iqbal 'Ike' Ahmed.
Author Disclosure Block: T.A. Bin Yameen: None. J. Armstrong: None. L. Scheres: None. P. Marolo: None. S. Lemmens: None. E. Chew: None. B. Khouri: None. H. Beckers: Santen, Glaukos, Novartis InnFocus Inc, Santen, Glaukos, Nova Eye Medical. A. Fea: None. I. Stalmans: None. C. Sng: ; Alcon, Allergan, Ivantis, Santen, Santen, Glaukos, Zeiss. Paul Glaucoma Implant. W. McCollum: None. J. Battle: None. M. Schlenker: ; Santen Pharmaceutical Co., Alcon, Allergan, Aequus Pharmaceuticals, Johnson & Johnson Vision, Labtician Théa,Light Matter Interaction Inc.. I. Ahmed: Aequus, Aerie Pharmaceuticals, Akorn, Alcon, Allergan, Aquea Health, Inc, ArcScan, Bausch Health, Beaver Visitec, Beyeonics, Carl Zeiss Meditec, Centricity Vision, Inc, CorNeat Vision, Costum, ELT Sight, ElutiMed, Equinox, eyeFlow, Inc, Genentech, Glaukos, Gore, Iantrek, InjectSense, Iridex, iStar,, Ivantis, Johnson & Johnson Vision, LayerBio, Leica Microsystems,, Long Bridge Medical, Inc, MicroOptx, MST Surgical, Mundipharma, New World Medical, Ocular Instruments, Ocular Therapeutix,, Oculo, Omega Ophthalmics, PolyActiva, Radiance Therapeutics, Inc, Ripple Therapeutics, Sanoculis, Santen, Shifamed, Sight Sciences, Smartlens, Inc:, Stroma, Thea Pharma, ViaLase,Vizzario.
Purpose: To compare surgical success, risk factors and post-operative course of the SIBS microshunt, gelatin microshunt, and trabeculectomy with mitomycin C (MMC) as a primarysurgical intervention in patients with glaucoma.
Study Design: We present a multicenter, 12-month, retrospective, non-randomized, interventional case series.
Methods: Consecutive patients with glaucoma received either primary SIBS microshunt, gelatin microshunt, or trabeculectomy with MMC as a stand-alone procedure at one of six participating centers (Canada, Italy, Netherlands, Belgium, Singapore, Dominican Republic) from August 2015 to August2020. Main outcome measures were proportion of eyes at 12-months with (1) no 2 consecutive IOPs > 17 mmHg or clinical hypotony, without (complete) or with (qualified) glaucoma medications; and (2) ≥20% reduction from baseline IOP. Secondary outcomes included IOP thresholds of 14 mmHg and 21 mmHg, median IOP, medications, risk factors, post-operative interventions, complications, and reoperations.
Results: Records from 643 eyes with SIBS microshunt (n=306), gelatin microshunt (n=198) or trabeculectomy (n=139) were included. After 12-months follow up, complete success occurred in 65% of patients with SIBS microshunt, 42% with gelatin microshunt and 58%% with trabeculectomy. Qualified success occurred in 85%, 69% and 85% of eyes, respectively. In the multivariate analysis, receiving intra- operative MMC less than 0.4mg/ml was significantly associated with failure (HR 1.5; 95%CI 1.2-2.0).
Complications occurred in 43%, 48% and 69% of eyes; needling in 10%, 29% and 22%; and reoperations in 7%, 11% and 6% with SIBS microshunt, gelatin microshunt, or trabeculectomy, respectively.
Conclusions: Overall, patients with the SIBS microshunt achieved success rates similar to trabeculectomy, but with fewer post-operative complications and interventions. Patients receiving the gelatin microshunt experienced lower success rates, with higher complications, interventions, and reoperations relative to SIBS microshunt and trabeculectomy.